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Alzheimer DiseasePhase 3NCT03197740

A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease

A Phase 3 study testing Donepezil patch and aricept Tab in people with Alzheimer Disease, run by Icure Pharmaceutical Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch in patients with mild to moderate Alzheimer's disease. The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301 (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Donepezil patch and aricept Tab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
1 siteSouth Korea
Study dates
12 Oct 2017to 20 Jul 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of ≥50 to ≤85 as of the date of informed consent
  • Clinical diagnosis of probable Alzheimer's disease according to Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) and National Institute of Neurological and Communicative Disorders and Strokes; Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA)
  • Mini Mental Status Examination (MMSE) score ≥10 to ≤26 at screening
  • Global Clinical Dementia Rating (CDR) score 0.5, 1 or 2 at screening
  • Capable of performing procedures for cognitive and other tests
  • Subject who meets any of the following as of the date of informed consent
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  • No past treatment with donepezil (naïve patient)
  • Ongoing treatment with donepezil 10mg/day for the past 3 months
  • Ongoing treatment with donepezil 5mg/day for the past 3 months
  • The subject or his/her representative must voluntarily decide to participate in the study and provide written informed consent.
  • The subject must have a reliable caregiver who regularly contacts the subject and is available to accompany the subject for on-site visits. (Note: A caregiver is defined as someone who has regular contact with the subject [i.e., an average of approximately 10 or more hours per week], must be able to oversee subject's compliance with the study treatment and to report on the patient's status and must be able to accompany the subject to all study visits.)

Who cannot join

  • Possible, probable, or definite vascular dementia according to National Institute of Neurological Disorders and Stroke/Association Internationale pur la Recherche et I'Enseignement en Neurosciences (NINDS-AIREN)
  • History and/or evidence (computed tomography [CT] or magnetic resonance imaging [MRI] findings obtained within the past 12 months or at screening) of other central nervous system (CNS) disorders (cerebrovascular disease, structural or developmental anomaly, epilepsy, or communicable, degenerative, or infectious/demyelinating CNS conditions) as a cause of dementia Note: >3 lacunar infarcts over 10 mm each, or severe white matter disease equaling a rating of 3 on the age-related white matter changes (ARWMC scale) should be excluded in the study.
  • Illiteracy
  • Treatment with other anti-dementia drugs (galantamine, memantine, rivastigmine, tacrine), except donepezil, within the past 3 months from the date of informed consent
  • Treatment with any of the following drugs within the past 2 weeks from the date of informed consent
  • CNS stimulants: methylphenidate, modafinil, pemoline, atomoxetine
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  • Typical antipsychotics: bromperidol, chlorpromazine, haloperidol
  • Anticholinergics: atropine, glycopyrrolate, scopolamine, homatropine, ipratropium (short term [within 3 days] use of anticholinergics for the purpose of antispasmodic action on the digestive system is permitted.)
  • Abnormal blood test findings as follows at the screening test:
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥2.5 x upper limit of normal
  • A serum creatinine level of ≥1.5 × ULN for the reference laboratory, or a calculated creatinine clearance by the Cockcroft-Gault equation of ≤50mL/min
  • Clinically significant abnormal vitamin B12, syphilis serology, or thyroid stimulating hormone (TSH) test findings considered to contribute to the severity of dementia or to be attributable to dementia
  • Note:
  • Clinically significant untreated B12 should be excluded in the study. Subjects are eligible if B12 deficiency is stable after the treatment.
  • If the subject has tested False positive for syphilis test, based on the investigator's judgment, further test can be performed to get the final result.
  • TSH >10mIU/L should be excluded in the study.
  • Diagnosis of serious mental disease based on DSM-5 criteria, including depressive disorder,, schizophrenia, alcoholism, drug dependency, etc.
  • Parkinson's disease or parkinsonian syndrome
  • Clinically significant electrocardiogram (ECG) abnormalities at screening (heart rate <50 beats/min, atrial and ventricular conduction disorders such as 2nd degree atrioventricular block, QTc interval >480ms)
  • History of unstable angina pectoris, myocardial infarction, transient ischemic attack, or coronary intervention including coronary bypass within the past 6 months from the date of informed consent
  • History of severe traumatic head injury with loss of consciousness within the past 6 months from the date of informed consent
  • Asthma or obstructive pulmonary disease requiring medication
  • Gastrointestinal disorders that may affect the absorption, distribution, and metabolism of the study drug (e.g., inflammatory bowel disease, gastric or duodenal ulcer, hepatic disease)
  • Uncontrolled diabetes mellitus (defined as HbA1c>9.0%)
  • Administration of other investigational products within 3 months prior to treatment with the investigational product (Day 0)
  • Hypersensitivity reactions to donepezil HCl, piperidine derivatives, or any of the components of the study drug
  • Pregnant or lactating woman or woman of childbearing potential who does not agree to use an effective method of contraception.
  • : Recommended effective methods of birth control include diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, and vasectomized partners. The subject/investigator can discuss any other best method that suits the subject.
  • Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Human immunodeficiency virus (HIV) positive or Acquired Immune Deficiency Syndrome (AIDs)
  • History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured, and cervical carcinoma in situ). Cancer survivors not on maintenance therapy that had no malignant disease history within the past 5 years could be recruited.
  • Individual considered by the investigator to be ineligible for study participation for other reasons, including having a condition that may affect the assessment of study results

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • 46 Sites including Konkuk University Medical Center

    Seoul

Other trials in South Korea

About this study

The objective of this study is to evaluate the efficacy and safety of donepezil transdermal patch in patients with mild to moderate Alzheimer's disease.

The primary objective is to demonstrate the non-inferiority of the test drug, IPI-301 (donepezil transdermal patch), to the comparator, Aricept tablet, after 24 weeks of treatment in patients with mild to moderate Alzheimer's disease in terms of improvement in cognitive function as assessed by the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) and in terms of global assessment as assessed by Clinician's Interview Based Impression of Change plus Caregiver Input (CIBIC-plus).

Being tested
Donepezil patch, aricept Tab
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donepezil patchDrug

    Treatment

  • aricept TabDrug

    Comparator

Study groups in NCT03197740
Study groupRoleWhat they receive
aricept Tab 5mgActive comparatorNot described
Receives: Drug: aricept Tab
donepezil patch 25cm2ExperimentalNot described
Receives: Drug: Donepezil patch
aricept Tab 10mgActive comparatorNot described
Receives: Drug: aricept Tab
donepezil patch 50cm2ExperimentalNot described
Receives: Drug: Donepezil patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ADAS-cog

    Change at Week 24 of treatment with the study drug from baseline (0d) in ADAS-cog scores

    Measured: week 24

Secondary outcomes (1)

  1. CIBIC-plus

    CIBIC-plus score at the end of treatment (Week 24)

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start12 Oct 2017
  3. Primary completion3 Jul 2020
  4. Study completion20 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197740
Sponsor's protocol ID
IPI-003
Status last verified
Feb 2021
First submitted
22 Jun 2017
Last updated
11 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Donepezil patch and aricept Tab in people with Alzheimer Disease, run by Icure Pharmaceutical Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADAS-cog (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03197740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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Clinical Trial NCT03197740 | AzTrials